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OpenTrials
Completed

NCT Number: NCT03646279

Thoracolumbar Brace for Individuals With Parkinson's Disease

This pilot study looked to see if a new brace would change the way people with Parkinson's Disease positioned their bodies. It also gathered information on the experience of wearing the brace.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50-80 years of age
  • Diagnosed with Parkinson's Disease
  • Participant self-reports mild difficulty with posture
  • Independent in ambulation without an assistive device (i.e., no walker or cane)
  • Able to give consent determined via telephone screen assessment or at minimum can follow simple directions
  • Able to tolerate 5 minutes of standing or walking at a time per self-report

Exclusion criteria

  • Rigid or fixed spine, as determined by self-report and use of thoracolumbar flexibility screen
  • Symptoms present before the age of 50
  • Other neurologic diagnosis, as determined by self-report
  • Spinal surgery
  • Lives in a nursing home or skilled facility
  • Uncorrected vision loss
  • Skin that is sensitive to tape or extremely fragile
  • Recent surgery (within the last 3 months) that affects mobility, as determined by self-report
  • Chest pain at rest or with activity per self report
  • Shortness of breath with daily activity per self report
  • Severe orthostatic hypotension assessed during in-person screen with sitting and standing blood pressure, evidenced by a 20-point drop in systolic blood pressure or 10-point drop in diastolic blood pressure and symptoms (e.g., dizziness) that don't resolve in 5 minutes.
  • High blood pressure 180/110 resting or systolic blood pressure <90 mmHG
  • Resting heart rate > 100 bpm or <50 bpm
  • Waist circumference < 31" or > 51" that would prevent proper fitting of CALIBRACE.

Treatment and study plan

Calibrace

Device

The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.

Primary outcomes

  1. Postural Alignment - Neck Position

    Time frame: In a single session, 10 data points per phase were collected

    Measured using PostureScreen Mobile Application and all measured bilaterally

    Neck position measured from (EAM to Acrominom)

    • angulation in degrees (flexion values positive/extension values negative)
    • translation in inches (anterior values positive and posterior values negative)
  2. Postural Alignment - Trunk Position

    Time frame: In a single session, 10 data points per phase were collected

    Measured using PostureScreen Mobile Application and all measured bilaterally

    Trunk position measure form Acrominom to Greater Trochanter of femur,

    • angulation in degrees (flexion values positive/extension values negative)
    • translation in inches (anterior values positive and posterior values negative)
  3. Postural Alignment - Hip/Knee Position

    Time frame: In a single session, 10 data points per phase were collected

    Measured using PostureScreen Mobile Application and all measured bilaterally

    Hip/knee position measured from greater trochanter of femur to lateral epicondyle of femur

    • angulation in degrees (flexion values positive/extension values negative)
    • translation in inches (anterior values positive and posterior values negative)

Secondary outcomes

  1. Postural Sway - Center of pressure position

    Time frame: Single session

    The mean center of pressure location measured in root mean squared through the average of three trials of eyes open and the average of three trials of eyes closed.

  2. Postural Sway - Center of pressure velocity

    Time frame: Single session

    The mean center of pressure velocity measured in meters/second through the average of three trials of eyes open and the average of three trials of eyes closed.

  3. Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation

    Time frame: Single Session

    Survey/interview with seven 4 points Likert-type rating scale (Strongly Disagree, Disagree, Agree, Strongly Agree). High numbers represent more agreement. and three open-ended questions

    There are no total or subscale scores. The frequency of ratings by participants, by the question is what is reported.

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

  • AbiliLife

Registry information

Official study title

Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 24, 2018
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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